Adigun Muyiwa, Ojebuyi Babatunde, Akinyemi Joshua, Wahab Kolawole, Akpalu Albert, Sarfo Fred S, Owolabi Lukman F, Musbahu Rabiu, Bello Abiodun, Obiako Reginald, Ogunronbi Mayowa, Nichols Michelle, Jenkins Carolyn, Jegede Ayodele, Kalaria Rajesh, Owolabi Mayowa, Ovbiagele Bruce, Arulogun Oyedunni, Akinyemi Rufus
Department of Public Law, Faculty of Law, University of Ibadan, Ibadan, Nigeria.
Department of Communication and Language Arts, Faculty of Arts, University of Ibadan, Ibadan, Nigeria.
Theory Pract Legis. 2021;9(3):404-424. doi: 10.1080/20508840.2022.2025741. Epub 2022 Jan 31.
Stroke is a major cause of death in Sub-Saharan Africa (SSA) and genetic factors appear to play a part. This led to the development of stroke bio-banking and genomics research in SSA. Existing stroke studies have focused on causes, incidence rates, fatalities and effects. However, scant attention has been paid to the legal issues about stroke bio-banking and genomics research in the sub-region. Therefore, this article examines how genomics research and stroke bio-banking in SSA can be regulated through legislation. The article reports that there are germane issues to be addressed such as appropriate consent model, commercial use of biological samples, ownership right in biological samples and return of research results but that the position of the law on these issues is not satisfactory because there are no statute directly regulating them while existing regulations in these countries are either absent, outdated, conservative or difficult to navigate. The article therefore applies the theory of symbolic legislation and argues for legislative intervention through positive symbolic approach. It recommends that the statute to be enacted should only address policy issues by way of legal rules without being detailed while the understanding of the rules should be fostered in explanatory notes. The explanatory notes should contain examples borne of decided cases, cases settled out of court and the ethical guidelines prepared by Human Heredity and Health in Africa (H3 Africa). Where they are inadequate, recourse may be had to other ethical guidelines subject to the demands of local circumstances.
中风是撒哈拉以南非洲地区（SSA）的主要死因之一，遗传因素似乎在其中起到了一定作用。这促使了SSA地区中风生物样本库及基因组学研究的发展。现有的中风研究主要集中在病因、发病率、死亡率及影响方面。然而，该次区域中风生物样本库及基因组学研究的法律问题却很少受到关注。因此，本文探讨了如何通过立法对SSA地区的基因组学研究及中风生物样本库进行监管。文章指出，存在一些亟待解决的相关问题，如适当的同意模式、生物样本的商业用途、生物样本的所有权以及研究结果的反馈等，但法律在这些问题上的立场并不令人满意，因为没有直接规范这些问题的法规，而这些国家现有的法规要么缺失、过时、保守，要么难以操作。因此，本文运用象征性立法理论，主张通过积极的象征性方法进行立法干预。建议即将颁布的法规仅通过法律规则来解决政策问题，而不涉及细节，同时应在解释性说明中促进对这些规则的理解。解释性说明应包含已决案件、庭外和解案件以及非洲人类遗传与健康组织（H3 Africa）制定的伦理准则中的实例。若这些实例不足，可根据当地情况参考其他伦理准则。
